Se nedtill hur TLVs motsvarighet i Frankrike arbetar
Kanske kan TLV lärdom hur en motsvarande process kring medicinteknik i Sverige kan ske.
Istället för att TLV skickar ut en uppgiven press release 170529 - efter drygt ett års arbete.
Frankrikes har fokuserat på den behandling patienterna faktiskt behöver.
1. Först gjorde man en en HTH-analys via Haute Autorité De Santé.
2. Sedan gjorde man en nationell prisförhandling.
3. Utfallet blev estimerat 300 000 individer med diabetes dvs flerdosbehandlade T1 och T2 DM.
Se nedtill specifikt för enskilda patientgrupper, ålder etc.
Se nedtill specifikt för enskilda patientgrupper, ålder etc.
Sverige har mycket mer real world evidens genom antalet patienter som redan använder systemet. Både från Örebro, Lund och Göteborg etc finns sådana data.
Efter 12/7 2016 har ännu fler referee-granskade artiklar kring FIGM-Libre/CGM publicerats.
Nyhetsinfo
www red DiabetologNytt
www red DiabetologNytt
Haute Autorité De Santé HAS
National Committee for the Evaluation of Medical Devices and Health Technologies
(CNEDiMTS
CNEDiMTS Review
12th July 2016
Following the inspection dated 28th June 2016, CNEDiMTS adopted the draft review on 12th July 2016
Conclusions
FREESTYLE LIBRE Flash Glucose Monitoring System
Applicant: ABBOTT France S.A.S.
Manufacturer: ABBOTT (USA)
Retained Indications:
Measuring interstitial glucose levels in the treatment of patients with type 1 or type 2 diabetes (adults and children aged at least 4 years) undergoing intensified insulin therapy (using an external insulin pump or ≥ 3 injections per day) and performing self-monitoring of blood glucose (SMBG) several times a day (≥ 3 per day).
The FREESTYLE LIBRE system is especially designed for patients who have received therapeutic education and specific training on the use of the flash interstitial glucose monitoring system.
Actual Benefit (AB):
Sufficient, due to:
· The diagnostic value of the FREESTYLE LIBRE system
· The interests of public health due to the seriousness of complications caused by type 1 or type 2 diabetes
Retained Comparator:
Self-monitoring of blood glucose using a single capillary blood glucose meter
Added Clinical Value (ADV)
ASA Level III
Type of Inclusion on Reimbursement List:
Brand name
Duration of Inclusion:
5 years
Analyzed Data:
- Two prospective non-randomized, multi-center studies to evaluate the performance of the FREESTYLE LIBRE system in terms of accuracy and precision, compared to the values of capillary blood glucose on 75 patients, and 89 adult patients aged 4-17 years, treated with insulin.
- A randomized controlled study, to evaluate, in 239 patients with type 1 diabetes on insulin pumps or on multiple daily injections (IMPACT study), the impact of using FREESTYLE LIBRE on the time spent in hypoglycemia (< 70 mg/dl), compared to a control group performing capillary blood glucose monitoring.
- A randomized controlled study to compare, in 224 patients with type 2 diabetes on insulin (REPLACE study), the level of HbA1c at 6 months in the FREESTYLE LIBRE group, compared to the clinical control group performing capillary blood glucose monitoring.
Factors Determining the Actual Benefit:
Technical Specifications:
No additional requirements proposed by the manufacturer with respect to the technical specifications.
Warranty period:
- The FREESTYLE LIBRE Reader: 4 years
- The FREESTYLE LIBRE Sensor: 14 days
In case of the product failing within the warranty period, the defective Reader shall be replaced with a new one within 3 working days.
Prescription and Terms of Use:
Prescription:
The initial prescription of the FREESTYLE LIBRE system must be ensured by a diabetologist or a pediatric diabetologist.
Initiation phase:
Before issuing a long-term prescription, the arrangements shall allow the provision of the FREESTYLE LIBRE system for:
- A trial period of a minimum of one month for every patient candidate of the FREESTYLE LIBRE system. This period should allow patients who are capable of using the FREESTYLE LIBRE and wearing the Sensor to be selected.
The criteria for termination of the trial may in particular be related to the patient’s own choice and/or that of his caregivers, poor skin tolerance to the Sensor, and the inability to wear a Sensor at all times.
- Towards the end of the trial period, patients who continue to use the FREESTYLE LIBRE system should undergo an evaluation at 3 months to assess whether or not to continue to use the system.
This assessment is based on the aforementioned criteria, in addition to a clinical assessment pertaining to the objectives set a priori (severe hypoglycemia, ketoacidosis decompensation, time spent above or below a certain hypoglycemic threshold), and/or biological (HbA1c).
Renewal:
Renewal is ensured by any doctor.
Patient-specific education and/or their caregivers:
Prior to prescription, patients should receive specific education to provide them with the necessary skills and knowledge to apply the Sensor and to interpret and use the information provided by the FREESTYLE LIBRE system to optimize their treatment. The patient should also be informed of the lower reliable results of the FREESTYLE LIBRE system 1st day after sensor application. This training is provided by a pump center or any other center that provides care for diabetic patients and is involved in therapeutic education programs validated by the Regional Health Agencies (ARS)[1]. It is essential to plan this SMBG with the patient and/or his caregivers, by determining its frequency, the targets and therapeutic decisions to be taken based on results.
Terms of reimbursement :
FREESTYLE LIBRE includes a capillary blood glucose meter. Terms of reimbursement for this device does not include any other capillary blood glucose meter. Terms of reimbursement of the FREESTYLE LIBRE system should allow the provision of the FREESTYLE LIBRE system elements, as a part of a long-term prescription: a Reader and Sensor (wearing time 14 days), following a 3-month initial period.
· The wearing time of the Sensor being 14 days, the total number of Sensors to maintain per year and per patient is limited to 28 Sensors.
· In clinical situations, where the manufacturer recommends measuring blood glucose, the capillary blood glucose meter test strips and lancets must be limited to 100 test strips and 100 lancets, per patient, per year.
Terms of Use:
Measuring interstitial glucose using the FREESTYLE LIBRE system requires patient intervention via a scan of the Reader over the Sensor to get a current glucose reading. In the case of occasional scanning (> 8 hours), the first values become lost. The device is designed to replace the capillary blood glucose measurement, except in the cases listed below where the manufacturer recommends the use of a capillary blood glucose meter to check the results of the glucose levels.
The different cases are as follows:
- In the case of rapidly changing glucose levels, the level of interstitial glucose, as measured by the Sensor and reported as actual, may not accurately reflect blood sugar levels. When glucose levels are rapidly dropping, the results of interstitial glucose levels measured with the Sensor may be higher than the blood glucose levels. Conversely, when glucose levels are rapidly increasing, interstitial glucose results measured with the Sensor may be lower than the blood glucose levels.
- In order to confirm hypoglycemia, or impending hypoglycemia, as reported by the Sensor.
- If symptoms do not match the FREESTYLE LIBRE system readings. Symptoms that may be caused by hypoglycemia or hyperglycemia should not be ignored.
No on-call duty 24/7 is required in case of system failure.
No preventive maintenance is required for the FREESTYLE LIBRE system.
Renewal Conditions:
Updating data as recommended by the practice guidelines for inclusion in the reimbursement list of products and services.
Target Population:
Approximately 300,000 patients.
Definitive Review 1
EVIDENCE REVIEW
01 NATURE OF THE APPLICATION
Application for inclusion on the list of products and services qualifying for reimbursement, mentioned under article L 165-1 of the Social Security Code (referred to as LPPR in the rest of the document).
01.1. MODELS AND REFERENCES
01.2. PACKAGING
The system comes in a Reader Kit and a Sensor Kit.
The Reader Kit includes:
1 FREESTYLE LIBRE Reader 1 USB Cable 1 Power Adapter Quick Start Guide User Manual
The Sensor Kit includes:
1 Sensor Pack 1 Sensor Applicator 1 Alcohol Wipe Product Leaflet
01.3. CLAIMED INDICATION
Measuring interstitial glucose levels for the treatment of patients with type 1 or type 2 diabetes (adults and children aged at least 4 years) undergoing intensified insulin therapy (using an external insulin pump or multiple injections).
01.4. CLAIMED COMPARATOR
Self-monitoring of blood glucose by capillary sampling (reference method).
02 REIMBURSEMENT HISTORY
This is the first application for inclusion on the LPPR for FREESTYLE LIBRE.
03 CHARACTERISTICS OF THE PRODUCT
03.1. CE MARKING
Class IIb, notification by the British Standards Institution (No. 597686), United Kingdom.
03.2. DESCRIPTION
The Flash Interstitial Glucose Monitoring System FREESTYLE LIBRE consists of two main parts:
- A Reader that is used to get the interstitial glucose readings from the Sensor by scan (scan of the Reader above the Sensor). Scanning can be done over clothing and requires a maximum distance of 4 cm between the Reader and Sensor to obtain readings.
With every scan, the user receives a reading of the current interstitial glucose level, the last 8 hours of glucose data and an arrow indicating the direction and rate of the glucose change. A glucose pattern and variability report can be generated.
The Reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time; as well as the notes entered by the user about his daily activities, such as taking insulin, eating food or exercising.
The Reader also allows the measurement of blood glucose and blood ketones of capillary blood sampling. It works using the glucose and blood ketone electrodes FREESTYLE OPTIUM.
- A Sensor that is inserted by the patient subcutaneously on the back of the upper arm with a simple applicator unit (only); it measures and stores interstitial glucose levels.
It comprises a sterile, flexible filament (0.4 mm thick), which is inserted 5 millimeters under the skin, into the interstitial fluid. The filament is connected to a small, 5 mm high and 30 mm diameter round disc and held in place on the skin with a small medical adhesive.
The Sensor can be worn for up to 14 days. It is water-resistant up to 1 meter (3 feet) of water for a maximum of 30 minutes. No calibration is recommended by the manufacturer within 14 days of usage.
The manufacturer also indicated that the Sensor can be used to check the glucose level 60 minutes after start-up.
The Sensor automatically measures and continuously stores glucose readings and stores up to 8 hours of glucose readings at 15 minute intervals. Therefore, in order to obtain all glucose data over a typical day, the patient should scan over the Sensor at least every 8 hours. In the event of scans spaced apart over a longer period (> 8 hours), the initial data is lost.
The operating temperature (Sensor and Reader) is between 10 and 45 degrees Celsius.
03.3. FUNCTIONS PROVIDED
Interstitial glucose measurement.
04 EXPECTED BENEFIT OF THE PRODUCT OR SERVICE
04.1. BENEFIT OF THE PRODUCT
04.1.1. DATA ANALYSIS: ASSESSMENT OF THE THERAPEUTIC EFFECT /ADVERSE EFFECTS AND RISKS
LINKED TO USE
04.1.1.1. SPECIFIC DATA
The IMPACT Study, unpublished[2], was an open, multicenter (23 centers) randomized controlled study. The purpose of the study was to assess the impact, after completion of 6-months use of FREESTYLE LIBRE on the time spent in hypoglycemia [number of hours per day <70 mg/dL], compared to a control group performing self-monitoring of blood glucose (SMBG) by capillary sampling. The patients analyzed were diabetic adults with type 1 diabetes, using intensive insulin treatment with either an insulin pump or multiple daily injections, (N= 239) with an HbA1c level of 6.74 ± 0.56% (144/239 patients (60.3%) had an HbA1c <7.0%).
The time spent in hypoglycemia was significantly lower in the FREESTYLE LIBRE group compared to the control group (mean difference -1.24 ± 0.239 hours per day (p <0.0001), at 6 months).
The results obtained after the completion of multiple analyses in favor of FREESTYLE LIBRE tackled the time spent in the target range (70 to 180 mg/dL) with a mean difference of 1 ± 0.30 hours per day (p = 0.0006) between the groups at 6 months; time spent in hyperglycemia (> 240 mg/dL) with a difference of -0.37 ± 0.163 hours per day (p = 0.0247); maximum satisfaction score [in the Diabetes Treatment Satisfaction Questionnaire (DTSQ)]; and the treatment satisfaction score in the [Diabetes Quality of Life questionnaire (DQoL)].
The results did not show any difference between the FREESTYLE LIBRE group and the control group tackled concerning the mean reduction in HbA1c at 3 and 6 months; the time spent in hyperglycemia > 180 and 300 mg/dL; the other dimensions of the DTSQ and DQoL scores, the HFS scores (Hypoglycemia Fear Survey) and the DDS (Diabetes Distress Screening) scores.
With respect to the number of tests in the intervention group, the mean number self-monitoring blood glucose (SMBG) jumped from 5.5 ± 2 tests per day (between 0 and 15 days) to 0.6 ± 0.1 tests per day at 6 months. The mean number of scans decreased from 18.5 ± 9.4 tests per day to 14.5 ± 9.8 tests per day at 6 months.
In the control group, the mean frequency of self-monitoring of blood glucose (SMBG) went from 5.8 ± 1.7 tests per day (between 0 and 15 days) to 5.6 ± 2.2 test per day at 6 months. The Sensor wearing time in the FREESTYLE LIBRE (between day 15 and day 208) was between 40% and 99%, with an average of 92.8 ± 7.3%.
The study is explained in detail in the Appendix.
The REPLACE Study, unpublished[3], is an open, multicenter (26 centers), randomized controlled study. The purpose was to compare the HbA1c (glycated hemoglobin A1c) level at 6 months between FREESTYLE LIBRE group (N.of patients = 149) and a control group (N. of patients= 75), performing self-monitoring of blood glucose (SMBG) by capillary sampling. Patients included in the study were adults with type 2 diabetes on insulin (N= 5/224 (2.2%), either treated with prandial insulin alone, N= 207/224 (92.4%), or with prandial and basal insulin; and 12 patients (5.4%) treated by insulin pump, with an HbA1c level between 7.5% and 12.0% (average 8.68%).
The results indicated no statistically significant difference between both groups in terms of reducing HbA1c at 6 months (average of 0.03% ± 0.114, p = NS).
With respect to the quality of life questionnaires, the results were in favor of FREESTYLE LIBRE on the maximum satisfaction score in the DTSQ (Diabetes Treatment Satisfaction Questionnaire) and the treatment satisfaction score in the DQoL (Diabetes Quality of Life) questionnaire.
Other dimensions of the DQoL and the DDS (Diabetes Distress Screening) scale showed no difference between the groups.
With respect to the number of tests in the intervention group, the mean number self-monitoring blood glucose (SMBG) was 0.3 ± 0.7 tests per day and the mean number of scans 8.3 ± 4.3 tests per day (between day 15 and day 208). In the control group (N = 51), the mean number self-monitoring blood glucose (SMBG) was 3.0 ± 1.1 tests per day. The Sensor wearing time in the FREESTYLE LIBRE group (between day 15 and day 208) was between 48% and 99%, with an average of 88.7 ± 9.2%.
The study is explained in detail in the Appendix.
The BAILEY et al. Study is a prospective, non-randomized, multicenter (involving 4 centers in the US) study using the FREESTYLE LIBRE device in hidden mode.
The purpose of this study was to evaluate the performance and usability of the FREESTYLE LIBRE Flash glucose monitoring system compared with capillary blood glucose (BG) results.
In total, 75 adult patients with type 1 or 2 diabetes treated with insulin were selected; the follow-up period was 14 days.
The primary endpoint was the percentage of paired points (FREESTYLE LIBRE / SMBG) found within Consensus Error Grid Zone A. (zone corresponding to clinically accurate readings, which is clarified as having “no effect on clinical action.”).
The analysis indicated that 86.7% of the results achieved by the FREESTYLE LIBRE device were found within Consensus Error Grid Zone A[4], compared with the results obtained by capillary sampling. On the first day of use, 72% of the results were within Consensus Error Grid Zone A.
The BEAGLE, Edge et al. Study, unpublished[5], is a prospective, non-randomized, multicenter (involving 9 centers in the UK), using the FREESTYLE LIBRE device in hidden mode.
The objective of this study was to assess the accuracy of the readings on the FREESTYLE LIBRE device on children in ambulatory use.
A total of 89 patients were included in the study. Patients were aged 4-17 years, with type 1 or 2 diabetes and were treated with insulin.
The primary endpoint was the percentage of paired points (FREESTYLE LIBRE / SMBG) found within Consensus Error Grid Zone A (zone corresponding to clinically accurate readings, which is clarified as having “no effect on clinical action”).
The analysis indicated that 83.8% of the results achieved by the FREESTYLE LIBRE device were found within
Consensus Error Grid Zone A, compared with the results obtained by capillary sampling.
04.1.1.2. MATERIOVIGILANCE
FREESTYLE LIBRE has been marketed and distributed since September 2014. 17 materiovigilance (post-market surveillance) statements have been received by the National Agency for the Safety of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé or ANSM) between 2014-2015.
Materiovigilance statements included skin reactions (N = 9) and result discrepancies between the scan and capillary blood glucose (N = 8). The number of Readers sold is 17,174, including samples (between September 2014 to May 2016).
The application is based on two specific randomized, controlled clinical studies (one specific to type 1 diabetics and the other to type 2 diabetics) and two accuracy studies. The data highlights the feasibility of usage of the FREESTYLE LIBRE device in terms of accuracy.
The first study (IMPACT) evaluates the clinical benefit of the FREESTYLE LIBRE device in adult patients with type 1 diabetes using intensive insulin treatment with either an insulin pump or multiple daily injections, with an average HbA1c level of 6.74 %. The time spent in hypoglycemia (<70 mg/dL) was significantly lower in the FREESTYLE LIBRE group compared to the control group (average difference -1.24 hours per day at 6 months. There was no difference in terms of the mean reduction in HbA1c levels between the groups.
The second clinical study (REPLACE) targets a population of adult patients with type 2 diabetes using insulin with an average HbA1c level of 8.68%. This study did not reveal any difference in terms of HbA1c reduction at 6 months. The study was not specific to patients using intensive insulin therapy.
In these two clinical studies, the results from the diabetes quality of life questionnaire (DQoL) were in favor of the FREESTYLE LIBRE, in terms of patient satisfaction.
With respect to safety and tolerance data, adverse events in clinical trials were primarily related to reactions around the Sensor insertion site (skin rash, infections, allergies, erythemas and necrosis). The number of incidents reported in the context of a materiovigilance (post-market surveillance) statement was low.
The available data does not allow assessment of the impact of the FREESTYLE LIBRE device on the frequency of prevented events or their consequences. However, the decrease of time spent in hypoglycemia (<70 mg/dL) and increased time spent in the target range are likely to protect the patient from the occurrence of severe hypoglycemia. Interpretation of the results obtained from the secondary endpoints of the studies was limited, given the multiplicity of the criteria being evaluated.
The National Professional Council for Endocrinology, Diabetes and Metabolic Diseases and the Federation of Associations of patients with diabetes in France were interviewed by the Commission. They confirmed the actual benefit of the FREESTYLE LIBRE system in the indications and defined the conditions for its prescription and use. Reliable results of the FREESTYLE LIBRE system as of the first day of set-up have however been brought to the attention of the Commission.
04.1.2. ROLE IN THE DIAGNOSTIC STRATEGIES
Glycemic control is the main objective of medical care for patients with diabetes to prevent long-term vascular complications and acute metabolic complications.
Pharmacological treatment of glycemic control in insulin-dependent type 1 and type 2 diabetes is based on an insulin therapy that mimics the normal physiologic pancreatic insulin secretion due to a basal/ bolus regimen, obtained either by multiple injections or by pump.
The choice between intensive insulin treatment with either an insulin pump or multiple daily injections is primarily based on patient preferences.
Self-monitoring of blood glucose is essential in insulin-treated patients. It should be performed daily using a capillary blood glucose meter (at least 4 times per day). This reading would allow patients to adjust treatment and is an ambulatory reference method.
Continuous measurement of interstitial glucose constitutes a new tool in the therapeutic arsenal against the disease. It complements conventional monitoring of capillary blood glucose but not a substitute.
Measuring interstitial glucose using the FREESTYLE LIBRE system requires patient intervention via a scan of the Reader over the Sensor to get a current glucose reading. In the case of occasional scan (> 8 hours), the first values become lost. The device is designed to replace the capillary blood glucose measurement, except in the cases listed below where the manufacturer recommends the use of a capillary blood glucose meter to check the results of the glucose levels.
The different cases are as follows:
-In the case of rapidly changing glucose levels, the level of interstitial glucose, as measured by the Sensor and reported as actual, may not accurately reflect blood sugar levels. When glucose levels are rapidly dropping, results of interstitial glucose levels measured with the Sensor may be higher than the blood glucose levels. Conversely, when glucose levels are rapidly increasing, the interstitial glucose results measured with the Sensor may be lower than blood glucose levels.
- In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor.
- If symptoms do not match the FREESTYLE LIBRE system readings. Symptoms that may be caused by hypoglycemia or hyperglycemia should not be ignored.
Systematic monitoring of HbA1c concentrations should be done 4 times per year. Measurement of fasting blood glucose carried out in a medical laboratory, allows self-monitoring of blood glucose (SMBG) and should be carried out once a year.
Continuous measurement of glucose levels (3 -5 days test) using a Continuous Glucose Monitoring System (CGMS) Holter-style Sensor system, provides a posteriori analysis by the doctor of glycemic excursions; it can be used to complement capillary blood glucose.
These last two readings are useful to the doctor to check the patient's glycemic control.
Given the data, the Committee considers that the FREESTYLE LIBRE system is beneficial in the management of diabetes and constitutes a new tool in the self-monitoring of blood glucose, according to interstitial glucose data, but does not completely replace it.
04.1.3. CONCLUSION ON THE BENEFIT OF THE PRODUCT
Given the available data and according to the National Professional Council for Endocrinology, Diabetes and Metabolic Diseases and the Federation of Associations of Patients with Diabetes in France, the Committee underscores the benefit of the FREESTYLE LIBRE device for the self-monitoring of interstitial glucose, within the provided indications and conditions for use.
04.2. PUBLIC HEALTH BENEFIT
04.2.1. SEVERITY OF THE PATHOLOGY
Diabetes is a serious condition due to the associated complications.
Acute complications of diabetes are metabolic emergencies (discomfort or coma) due to hyperglycemia, ketoacidosis or hypoglycemia.
Chronic and degenerative complications of diabetes are the leading cause of morbidity and death with this disease. They include the microvascular complications (retinopathy, glomerular disease and neuropathy) and macrovascular complications (coronary heart disease, cerebrovascular and peripheral artery disease [PAD]).
Diabetes is a serious disease due to complications that may occur but are preventable when the metabolic control of blood sugar is permanently achieved.
04.2.2. EPIDEMIOLOGY OF THE PATHOLOGY
Results of the 2007-2010 Entred survey have estimated that 2.4 million adults in France suffer from diabetes. In 2013, the French Institute for Public Health Surveillance (InVS) estimated that over 3 million patients are being treated for diabetes.
Type 2 diabetes is the most common form (92%, or 2.76 million people in France). Patients with type 2 diabetes treated with insulin account for 17% of type 2 diabetes patients (469,200 patients).
Patients with type 1 diabetes account for 5.6% of diabetic patients, i.e. approximately 168,000 patients.
According to Entred, there are approximately 12,000 children with diabetes; they mainly suffer type 1 diabetes.
The total number of diabetic patients who have type 1 diabetes account for 170,000 patients. The total number of patients with type 2 diabetes treated with insulin is estimated at 470,000.
04.2.3. IMPACT
Blood glucose monitoring is provided by capillary blood glucose meters. No interstitial blood glucose scanner is currently listed on the LPPR.
This type of medical device constitutes a new tool in the arsenal of diabetes self-monitoring devices.
04.2.4. CONCLUSION ON PUBLIC HEALTH BENEFITS
Due to the expected reduction of the occurrence of long-term complications from diabetes and severe hypoglycemia; and given the severity of the pathology, the Committee estimates that the FREESTYLE LIBRE system provides a public health benefit.
In conclusion, the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) believes that Actual Benefit is sufficient for inclusion on the list of products and services qualifying for reimbursement mentioned under article L 165-1 of the Social Security Code.
The Commission recommends inclusion of the product under brand name and retains the following indications:
Measurement of interstitial glucose levels for the treatment of patients with type 1 or type 2 diabetes (adults and children aged 4 years) undergoing intensified insulin therapy (using an external insulin pump or ≥ 3 injections per day) and performing the self-monitoring of blood glucose (SMBG) several times a day (≥ 3 per day).
The FreeStyle Libre System is especially designed for patients who have received therapeutic education and specific training on the use of the flash interstitial glucose monitoring system.
05 FACTORS DETERMINING THE ACTUAL BENEFIT
05.1. MINIMUM TECHNICAL SPECIFICATIONS
No additional requirements with respect to the technical specifications proposed by the manufacturer.
Warranty period:
- The FREESTYLE LIBRE Reader: 4 years
- The FREESTYLE LIBRE Sensor: 14 days
05.2. TERMS OF USE AND PRESCRIPTION
Prescription:
The initial prescription of the FREESTYLE LIBRE system must be ensured by a diabetologist or a pediatric diabetologist.
Initiation phase:
Before issuing a long-term prescription, the arrangements shall allow the provision of the FREESTYLE LIBRE system for:
- A trial period of a minimum of one month for every patient eligible for FREESTYLE LIBRE system. This period should allow the selection of patients who are capable of using the FREESTYLE LIBRE and wearing the Sensor.
The criteria for termination of the trial may in particular be related to the patient’s choice and/or his caregivers, poor skin tolerance to the Sensor, or the inability to wear a Sensor at all times
- Towards the end of the trial period, patients who continue to use the FREESTYLE LIBRE system should undergo an evaluation at 3 months to assess whether or not to continue to use the system.
This assessment is based on the aforementioned criteria, in addition to a clinical assessment pertaining to the objectives set a priori (Severe hypoglycemia, ketoacidosis decompensation, time spent above or below a certain hypoglycemic threshold), and/or biological (HbA1c).
Renewal:
Renewal is ensured by any doctor.
Patient-specific education and/or their caregivers:
Prior to prescription, patients are supposed to receive specific education to provide them with the necessary skills and knowledge to apply the Sensor and to interpret and use the information provided by the FREESTYLE LIBRE system to optimize their treatment. The patient should also be informed of the lowest reliability of the FREESTYLE LIBRE system’s results upon installation. This training is provided by a pump center any other center that provides care for diabetic patients and is involved in therapeutic education programs validated by the Regional Health Agencies (ARS)[6]. It is essential to plan this SMBG with the patient and/or his caregivers, by determining its frequency, the targets and therapeutic decisions to be taken based on results.
Conditions for support:
FREESTYLE LIBRE includes a capillary blood glucose meter. Providing support and maintenance for this device does not include any other capillary blood glucose meter. The conditions for support of the FREESTYLE LIBRE system should allow the provision of the FREESTYLE LIBRE system elements, as a part of a long-term prescription: a Reader and Sensor (wearing time 14 days), following a 3-month initial period.
The wearing time of the Sensor being 14 days, the total number of Sensors to maintain per year and per patient is limited to 28 Sensors. In clinical situations, where the manufacturer recommends measuring blood glucose, the capillary blood glucose meter test strips and lancets must be limited to 100 test strips and 100 lancets, per patient, per year.
Terms of Use:
Measuring interstitial glucose using the FREESTYLE LIBRE system requires patient intervention via a scan of the Reader over the Sensor to get a current glucose reading. In the case of occasional scanning (> 8 hours), the initial values will become lost. The device is designed to replace the capillary blood glucose measurement, except in the cases listed below where the manufacturer recommends the use of a capillary blood glucose meter to check the results of the glucose levels.
The different cases are as follows:
- In the case of rapidly changing glucose levels, the level of interstitial glucose as measured by the Sensor and reported as actual may not accurately reflect blood sugar levels. When glucose levels are rapidly dropping, results of interstitial glucose levels measured with the Sensor may be higher than the blood glucose levels. Conversely, when glucose levels are rapidly increasing, interstitial glucose results measured with the Sensor may be lower than blood glucose levels.
- In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor.
- If symptoms do not match the FREESTYLE LIBRE system readings. Symptoms that may be caused by hypoglycemia or hyperglycemia should not be ignored.
No on-call duty 24h/24h is required in the case of system failure.
No preventive maintenance is required for the FREESTYLE LIBRE system.
06 ADDED CLINICAL VALUE (ACV)
06.1. RETAINED COMPARATOR
Self-monitoring of blood glucose using a single capillary blood glucose meter.
06.2. ACV LEVEL
The Commission emphasizes that patient comfort and improved quality of life due to lower capillary blood glucose by finger prick test improved with the FREESTYLE LIBRE system.
The Commission decided on a moderate Added Clinical Value (ACV III) of the FREESTYLE LIBRE versus Self-Monitoring of Blood Glucose (SMBG) by capillary blood glucose Reader alone.
07 CONDITIONS OF RENEWAL AND DURATION OF INCLUSION
07.1. RENEWAL CONDITIONS
Updating data, as recommended by the practice guidelines for inclusion in the reimbursement list of products and services.
07.2. DURATION OF INCLUSION
5 years.
08 TARGET POPULATIONS
The population using the FREESTYLE LIBRE device was estimated based on analysis of individual data on the reimbursement of healthcare expenses.[7]
The selection criteria were as follows:
- At least one insulin treatment reimbursed during 2015 (ATC code: A10A)
Associated to
- At least one capillary blood glucose meter strip reimbursed during 2015 (LPPR code: 1173487, 1136894, 1186722, 1180441, 1187408, 1177611, 1179337 and 1172861).
Results indicated that the number of individuals treated with insulin and using testing strips for capillary blood glucose meter in 2015 was:
- 288,963 based on a minimum of 1,095 strips reimbursed (which reflects a mean daily consumption of 3 strips or more).
-136,127 based on a minimum of 1,460 strips reimbursed (which reflects a mean daily consumption of 4 strips or more).
- 72,540, based on a minimum of 1,825 strips reimbursed (which reflects a mean daily consumption of 5 strips or more).
Bearing in mind that individual reimbursement reflects the actual use of the product and that the frequency of use of capillary blood glucose meter strips is linked to insulin injections, it is estimated that the number of patients performing at least 3 insulin injections per day would be approximately 300,000 per year.
ANNEX 1
CLINICAL DATA
All studies published in detail with results and conclusions
[1] Two decrees (D2010-904 and D2010-906) and two bylaws dated 2nd August 2010, setting the authorization procedures of patient education by the regional health agencies and the skills required to deliver these programs, have been published in the Official Gazette on 4th August 2010.
According to these texts, any implemented therapeutic education program must submit for authorization from the Regional Health Agencies (ARS).
[2] IMPACT Study Report ‘Randomized Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycemia in Type 1 Diabetes’ – 25th January 2016.
[3] REPLACE Study Report ‘Randomized Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes’- 23rd October 2015.
4 Bailey T., Bode B., Christiansen M., Klaff L., Alva S. et al. ‘The performance and Usability of a Factory-Calibrate Flash Glucose Monitoring System.’ ‘Diabetes Technol The.’ 2015; 17(11).
[4] Parkes JL et al, ‘A New Consensus Error Grid to Evaluate the Clinical Significance of Inaccuracies in the Measurement of Blood Glucose; Diabetes Care’ 23:1143-1148,2000.
[5] Edge J.A., Acerini C., Campbell F., Hamilton-Sheild J., Moudiotis C. ‘Clinical Accuracy Evaluation of the FREESTYLE LIBRE Flash Glucose Monitoring System When Used by Children and Young People with Diabetes’.
[6] Two decrees (D2010-904 and D2010-906) and two bylaws dated 2nd August 2010, setting the authorization procedures of patient education by the regional health agencies and the skills required to deliver these programs, have been published in the Official Gazette on 4th August 2010.
According to these texts, any implemented therapeutic education program must apply for authorization from the Regional Health Agencies (ARS).
[7] According to the Inter-scheme Consumption Data (données de consommation inter-régimes [DCIR]) database of Health Insurance; which compiles data on healthcare expenses paid to beneficiaries in France.
[8] Diabetes Treatment Satisfaction Questionnaire : 8 questions on a scale of 0 to 6, highest score = high satisfaction
[9] Diabetes Quality of Life: 46 items (on a scale of 0 to 5).
[10] Diabetes Distress Screening Scale
[11] Hypoglycemia Fear Survey